Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
Status:
RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
Primary Objectives
* In phase 1b cohort, to determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE) in combination with Ramucirumab (Cyramza) and TAS-102 (LONSURF)
* In phase II cohort, to evaluate disease objective response rate (ORR) of Ramucirumab (Cyramza), nal-IRI (ONIVYDE) in combination with TAS-102 (LONSURF) Secondary Objectives
* To evaluate disease control rate (DCR)
* To evaluate progression-free survival (PFS)
* To evaluate overall survival (OS)
* To assess the safety profile
* To study the blood biomarkers
Phase:
PHASE1
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital China Medical University Hospital Kaohsiung Medical University Chung-Ho Memorial Hospital National Cheng-Kung University Hospital Taipei Veterans General Hospital, Taiwan
Treatments:
irinotecan sucrosofate Ramucirumab tipiracil Trifluridine trifluridine tipiracil drug combination